The following data is part of a premarket notification filed by Flat Medical Co., Ltd. with the FDA for Epifaith Cv.
| Device ID | K212615 |
| 510k Number | K212615 |
| Device Name: | EpiFaith CV |
| Classification | Wire, Guide, Catheter |
| Applicant | Flat Medical Co., Ltd. 9F.-1 No. 27, Sec. 1, Chang'an E. Rd. Zhongshan Dist. Taipei City, TW 10441 |
| Contact | Tseng Shao Wei |
| Correspondent | Tseng Shao Wei Flat Medical Co., Ltd. 9F.-1 No. 27, Sec. 1, Chang'an E. Rd. Zhongshan Dist. Taipei City, TW 10441 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-18 |
| Decision Date | 2022-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14719875599030 | K212615 | 000 |